The 2010 pharmacovigilance legislation required EMA to publish the format for the electronic submission of information on medicinal products for human use by 2 July 2011.
EMA is more or less on track, and the just-released Electronic submission of information on medicines give a good sense of the four-step approach that the agency will take towards implementation:
- Phase one: Notification of the electronic submission format
- Phase two: Electronic submission by marketing-authorisation holders
- Phase three: Processing and validation of the submitted information
- Phase four: Update of the format in compliance with the ISO IDMP standards
The Agency published the format for the notification of the electronic submission of medicinal product information in July 2011, which lists all of the data elements required, including the description of the characteristics of the substances contained in medicinal products. The Agency updated this information in September 2011 to include the XML Schema Definition (XSD) for the individual data elements.
The Agency has published a list of controlled vocabularies, which companies should use to fill in fields of the extended EudraVigilance product report messages (XEVPRMs). This list is updated periodically. The XSD schema files and naming conventions for substances are also available.
[Thank you to Catherine Guilliaumet via the medical_translation list]
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